OTC Medicines

Scilex Citizen Petition requesting that FDA remove from the market and prevent further marketing of lidocaine-containing drug products that have not been approved pursuant to a new drug application or an abbreviated new drug application submitted under 21 U.S.C. § 355.

These comments are submitted as supporting evidence for the safety of the spray dosage from of sunscreens and is referenced in the comments filed to this docket by PCPC and CHPA.

Because of their well-established role in protecting public health, the significant benefits provided by sunscreens need to be appropriately weighed against any potential risks. We support FDA’s commitment to ensuring that sunscreens are safe and effective for their intended use.

The Personal Care Products Council and CHPA write in response to the proposed rule from FDA regarding sunscreen drug products for OTC human use. We write to request that the following sunscreen active ingredients be deferred from inclusion in the final rule.

We support FDA's commitment to ensuring that sunscreens are safe and effective for their intended use. We are confident that currently marketed sunscreens are both safe and effective.

CHPA welcomes the opportunity to comment on the draft guidance on indications for nicotine replacement therapies (NRT).